Official Journal of the European Union

EN

C series

—

C/2025/4318

11.8.2025

(Case T-407/25)

(C/2025/4318)

Language of the case: German

Parties

Applicant: Biofa GmbH (Münsingen, Germany) (represented by: C. Stallberg and C. Binder, lawyers)

Defendant: European Commission

Form of order sought

The applicant claims the Court should:

—annul Commission Implementing Regulation (EU) No 2015/2069 of 17 November 2015 approving the basic substance sodium hydrogen carbonate (<span class="oj-super oj-note-tag">1</span>) in the version of the review report for the basic substance sodium hydrogen carbonate of 9 October 2015 (SANTE/10667/2015 – rev. 5), in the version of that report dated 11 March 2025;

in the alternative,

annul the review report for the basic substance sodium hydrogen carbonate of 9 October 2015 (SANTE/10667/2015 – rev. 5), in the version dated 11 March 2025, in so far as, in that report, the use of sodium hydrogen carbonate as a basic substance is limited only for the indication ‘Vitis vinifera’ (vine) in Austria and Germany, and, moreover, the use of sodium hydrogen carbonate remains permitted in all authorised indications and Member States pursuant to Appendix II to the review report;

—order the defendant to pay the costs of the proceedings.

Pleas in law and main arguments

In support of its action, the applicant relies on a single plea in law, alleging infringement of the marketing criterion laid down in Article 23(1)(d) of Regulation No 1107/2009. (<span class="oj-super oj-note-tag">2</span>)

According to the applicant, the marketing criterion laid down in Article 23(1)(d) of Regulation No 1107/2009 confers on it, as the holder of the marketing authorisation for the plant protection product ‘NatriSan®’, a right to protection against the simultaneous approval of the substance sodium hydrogen carbonate as a basic substance.

In the light of the principle of harmonisation and the principle of effectiveness, the wording of Article 23(1)(d) of Regulation No 1107/2009 and the scheme of that regulation, it should be concluded that the approval of the basic substance is to be revoked in its entirety if the marketing criterion ceases to apply. The approval of a basic substance is granted by means of an implementing regulation, which should be applied uniformly throughout Europe in all Member States, and therefore be withdrawn uniformly if the approval criteria are no longer applicable.

The maintenance in force of Commission Implementing Regulation (EU) No 2015/2069 of 17 November 2015 approving the basic substance sodium hydrogen carbonate, in the version of the review report for the basic substance sodium hydrogen carbonate of 9 October 2015 (SANTE/10667/2015 – rev. 5), is therefore contrary to EU law and infringes the applicant’s rights.

—

Commission Implementing Regulation (EU) 2015/2069 of 17 November 2015 approving the basic substance sodium hydrogen carbonate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ 2015 L 301, p. 42).

Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ 2009 L 309, p. 1).

—

ELI: http://data.europa.eu/eli/C/2025/4318/oj

ISSN 1977-091X (electronic edition)

—